Eu Ivdd
Eu Ivd General
No Longer On The Market
🇨🇳 China
Sharay Anti-α-Fodrin IgG (CLIA)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06975070761370
- Basic UDI-DI Code
- B-06975070761370
- Reference
- 18190001
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- No Longer On The Market
- Manufacturer
- C-Luminary Biotechnology Co., Ltd.
Additional Description
Sharay Anti-α-Fodrin IgG (CLIA) is intended for the In Vitro qualitative measurement of IgG directed to α-Fodrin in human serum/plasma as an aid in the diagnosis of Sicca Syndrome (SS) in conjunction with other laboratory and clinical findings.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102100199 | AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).
BluBox
Device
EU IVDD
·
Eu Ivd General
·Blusense Diagnostics ApS·On the market·5 countries
extendSURE™ HbA1c Liquid Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·19 countries
ViroTrack Sero COVID-19 Total Ab
Device
EU IVDD
·
Eu Ivd General
·Blusense Diagnostics ApS·On the market·5 countries
extendSURETM Haemoglobin F and A2 Calibrators
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·8 countries
extendSURE™ Haemoglobin F and A2 Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·8 countries
extendSURE™ HbA1c Liquid Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·19 countries